CEVA: Oversight Group Management

Quintiles’ CEVA is a unique service clinical trial management service offering within the CRO industry.

CEVA is a specialized department located within Quintiles Pharmacovigilance which provides expert, integrated oversight group management for external trial components such as:

  • Endpoint Adjudication Committees (EACs) / Clinical Endpoint Committees (CECs)
  • Data Monitoring Committees (DMCs) / Data Safety Monitoring Boards (DSMBs)
  • Advisory Groups (e.g. Expert Panels, Steering Committees, Scientific Advisory Boards)
  • Core Laboratories and Central Reader Processes

CEVA offers a complete range of oversight group management services, from managing a single oversight group, to coordinating and integrating multiple oversight group processes on the same trial, to the management of all aspects of a customer’s oversight group management operations.

Full range of clinical trial management services

  • Identification, screening, qualification and selection of oversight group members
  • Confidentiality & Financial Disclosure Agreements, contracts, payments and reimbursements
  • Charter, Site Manual and Case Report Form development
  • Endpoint & Core Laboratory Data Coordinating Centers
  • Meeting planning and organization
  • Tracking and status reporting, filing and archiving

Finely-tuned experience

Through the management of activities for oversight group processes on 100 trials, we have formed strong working relationships with well over 500 clinical advisors in wide range of different specialties.

We have conducted 50 endpoint trials across multiple therapeutic areas and have processed over 56,000 endpoints for adjudication. This experience includes 14 global megatrials, ranging in size between 1000 and 13,000 endpoints.

We have coordinated over 45 independent DMC/DSMB processes spanning a broad range of indications.

We have managed 20 Core Laboratory processes in the following specialty areas: Angiography, CPX, CMR, CT Scans, ECG, Echocardiography, MRI, SPECT, Venography, VQ Scans. For 10 of these projects, it was necessary to include final Core Laboratory results in the dossiers we submitted to an Endpoint Adjudication Committee for review, and we successfully sequenced both dataflows to achieve timely completion of this objective.

We have supported 15 Advisory Group processes, working closely with over 100 thought leaders from multiple therapeutic areas.

Delivery of robust processes and quality results

The execution of our oversight group processes is governed by Standard Operating Procedures.

DMC/DSMB processes are managed in full compliance with FDA’s Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees.

Endpoint Adjudication processes managed by CEVA benefit from an average 1% rate for requests for additional documentation. This extremely low rate is reflective of true expertise and quality in the area of endpoint dossier preparation and is attributed to the fact that we have developed highly-specialized skills in the area of dossier content review.